Clinical Research CoordinatorCourse 5 of 8

Clinical Research Coordinator

Full course · Participant Management: Screening to Retention

IRB-approved recruitment materials: what you can and cannot say — Participant Management: Screening to Retention

IRB-approved recruitment materials: what you can and cannot say

Learn which recruitment materials require IRB approval, how to apply evaluation criteria, and how to avoid common compliance pitfalls including social media challenges.

25 min

Every word is a regulatory decision

A coordinator drafts a social media post for a diabetes prevention trial: "Free medication and $500 for participating in a groundbreaking study!" The post is enthusiastic. It is short enough for most platforms. And every word is a problem.

"Free medication" implies a therapeutic benefit that an investigational product cannot promise — the drug may not work, may be a placebo, and is not approved for use. "Groundbreaking" is a claim of scientific superiority that no IRB would allow. "$500" presented without context about what the compensation covers creates an impression of payment-for-participation rather than reimbursement for time and inconvenience. And "participating" without any mention of study procedures, risks, or eligibility criteria strips the message of the balanced information the IRB requires.

That single sentence, posted without IRB review, would violate FDA guidance, ICH E6(R3) requirements, and most institutional policies simultaneously. And yet this kind of error happens — not because coordinators are careless, but because the rules governing recruitment language are not intuitive. What sounds like effective marketing often violates the principles that protect potential participants from misleading information.

This lesson teaches you those rules. By the time you finish, you will be able to look at any recruitment material — a flyer in a waiting room, an Instagram post, a letter to physicians, a radio script — and identify exactly what is compliant, what is not, and why.

What you will learn4 objectives

By the end of this lesson, you will be able to:

Identify all categories of recruitment materials and communications that require IRB/IEC review and approval before use
Apply IRB evaluation criteria — accuracy, balance, reading level, compensation language, and contact information — to assess recruitment material compliance
Recognize common pitfalls in recruitment materials including curative claims, guaranteed payment language, and minimization of burdens
Navigate social media-specific recruitment considerations including character limits, comment moderation, and platform-specific disclosure requirements

Progress saves itself — finish reading and this lesson completes

This is just the beginning

Every word is a regulatory decision